Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation

Abstract

Introduction: Risankizumab has demonstrated efficacy and safety in phase 3 studies in patients with moderate to severe plaque psoriasis. This randomized clinical trial assessed the efficacy and safety of risankizumab in patients with moderate to severe plaque psoriasis in the Russian Federation.

Methods: Patients with moderate to severe plaque psoriasis were randomized 4:1 to 16 weeks of double-blind treatment with risankizumab 150 mg or placebo (period A; dosing at baseline and week 4) followed by an open-label extension (period B) during which all patients received risankizumab 150 mg at weeks 16, 28, and 40 and were followed up to week 52. The primary study endpoint was the proportion of patients achieving ≥ 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at week 16, and secondary endpoints included Static Physician's Global Assessment scores and the Dermatology Life Quality Index. Treatment-emergent adverse events were monitored throughout the two study periods.

Results: Of the 50 patients who entered period A, 41 were randomized to receive risankizumab and 9 to receive placebo. Forty-eight patients entered period B, and 47 completed the study. A significantly larger proportion of risankizumab-treated patients achieved PASI 90 at week 16 compared with placebo-treated patients [response rate difference: 38.8% (95% CI 7.8-69.7%; P = 0.035)]. Consistently higher proportions of risankizumab-treated patients achieved secondary endpoints compared with the placebo-treated patients. Safety profiles were similar between the treatment groups, and no patients discontinued the study drug owing to adverse events.

Conclusion: Risankizumab was efficacious and well tolerated in patients with moderate to severe plaque psoriasis in the Russian Federation.

Trial registration: ClinicalTrials.gov NCT03518047.

Keywords: Efficacy; Psoriasis; Risankizumab; Russia; Safety.

Fig. 1

Study design. Bold indicates study visit ± 3 days. BL baseline, DB double-blind, OL open-label, W week

Fig. 2

Patient disposition

Fig. 3

Proportions of patients achieving a sPGA 0, b sPGA 0/1, c PASI 75, d PASI 90, e PASI 100, and f percentage improvement from baseline in PASI. NRI analysis for panels a–e and LOCF for panel f. LOCF last observation carried forward; NRI nonresponder imputation; PASI 75/90/100 ≥ 75%/≥ 90%/100% improvement in Psoriasis Area and Severity Index; PBO placebo; sPGA static Physician’s Global Assessment; RZB risankizumab. *P < 0.05; ^†P < 0.001; ^‡P < 0.0001

Fig. 4

Proportions of patients achieving a DLQI 0 and b DLQI 0/1 and c change from baseline in DLQI. NRI analysis used for panels a, b and LOCF for panel c. DLQI Dermatology Life Quality Index, LOCF last observation carried forward, NRI nonresponder imputation, PBO placebo, RZB risankizumab. *Nominal P < 0.05; ^†nominal P < 0.001; ^‡nominal P < 0.0001